Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740136642
• Version / Model: 07P8410
• Catalog Number: 07P8410
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-11
• Public Version: 3
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: cafe82db-8045-4dab-b394-2ce6c3501c29

Device Description

Alinity i Anti-HBc Controls

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOM	Test, hepatitis b (b core, be antigen, be antibody, b core igm)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
41984	Hepatitis B virus core total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus core antigen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740136642	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P080023	028
P080023	040
P080023	042
P080023	043

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius